A new peptide-based drug-delivery strategy may bring scientists closer to
an oral form of insulin.

For more than 100 years, scientists have pursued the idea of delivering
insulin as a pill. This goal has remained difficult to achieve because
insulin breaks down in the digestive system and the intestine lacks a
natural transport pathway that allows the hormone to enter the bloodstream.

Because of these biological barriers, many people with diabetes still
depend on daily insulin injections, which can place a significant burden on
long-term treatment and quality of life.

Researchers at Kumamoto University, led by Associate Professor Shingo Ito,
have now developed a promising drug delivery strategy designed to overcome
these obstacles. Their approach uses a cyclic peptide that can pass through
the small intestine. The molecule, called the DNP peptide, helps insulin
move across the intestinal barrier and into the body after oral
administration.

Two Complementary Strategies for Oral Delivery

The researchers established two effective approaches to facilitate the
intestinal absorption of insulin:

Mixing method (interaction-based): In this approach, a modified “D-DNP-V
peptide” was mixed with zinc-stabilized insulin hexamers. When given orally
in several diabetes models, including chemically induced (STZ mice) and
genetic (Kuma mice) models, the treatment quickly lowered blood glucose
levels to the normal range. With once-daily dosing, stable glycemic control
was maintained for three straight days.

Conjugation method (covalent-based): In the second approach, the team used
click chemistry to directly attach the DNP peptide to insulin, creating a
“DNP–insulin conjugate.” This version produced glucose-lowering effects
similar to those seen with the mixing method, supporting the idea that the
peptide actively drives intestinal transport of insulin.

Overcoming the Dose Barrier

One of the biggest challenges in developing oral insulin has been the need
for very large doses, often more than ten times the amount used in an
injection. In contrast, this platform reached a pharmacological
bioavailability of about 33–41% compared with subcutaneous injection.

That finding suggests a major reduction in the amount of insulin required
for oral use and represents an important step toward real-world clinical
application.

DNP Peptide Based Delivery Platform May Support Future Oral Insulin
Development

Engineered DNP peptides—either fused to insulin-binding peptides or
covalently linked to insulin using click chemistry—directly enhanced
insulin absorption in mice. These findings demonstrate that DNP peptides
are versatile carriers for the oral delivery of macromolecular drugs,
offering a practical way to convert injectable biopharmaceuticals into
patient-friendly oral medicines. Credit: Chikamatsu et al.

Perspective

“Insulin injections remain a daily burden for many patients,” said
Associate Professor Shingo Ito. “Our peptide-based platform offers a new
route to deliver insulin orally and may be applicable to long-acting
insulin formulations and other injectable biologics.”

The findings were published in the international journal Molecular
Pharmaceutics.

The research team is now moving forward with translational studies. Planned
work includes testing the system in large animal models and evaluating its
performance in human intestinal systems.

Reference: “Small Intestine-Permeable Cyclic Peptide-Based Technology
Enables Efficient Oral Delivery and Glycemic Efficacy of Zinc-Stabilized
Insulin Hexamer and Its Analogs in Diabetic Mice” by Shoma Chikamatsu,
Kosei Sakaguchi, Masataka Michigami, Kimi Araki, Shoen Kume, Midori
Tokuyasu, Takeshi Masuda, Ikuo Fujii, Sumio Ohtsuki and Shingo Ito, 24
November 2025, Molecular Pharmaceutics.

KR IRS  19326

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